Who is the typical audience for a Quality Manual?

The audience includes regulatory auditors, certification bodies, new employees, and internal staff who need to understand the overarching structure and commitments of the QMS. It also serves as a reference for management.

How often should a Quality Manual be reviewed and updated?

A Quality Manual should be reviewed periodically, typically annually, and updated whenever there are significant changes to the QMS, such as new processes, products, or regulatory requirements. Changes must be controlled and approved.

All terms

Quality & RiskQuality System

Quality Manual

Top-level QMS document describing scope, processes, and their interactions.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

Definition

ISO 13485 §4.2.2 requires a Quality Manual that documents QMS scope, justifications for any exclusions, references to documented procedures, and a description of process interactions. The quality manual also outlines the structure of the documentation used in the QMS and is often the first document reviewed by auditors. ISO 13485 allows exclusions or non-applications, for example of design and development, only when justified and allowed by applicable regulations. Under the QMSR, FDA expects the quality manual as part of ISO 13485 conformance, which it previously addressed through the quality system record.

What the regulation says

The FDA, under 21 CFR 820.20, mandates a Quality System Manual or equivalent document that outlines the quality system. Similarly, the EU Medical Device Regulation (EU MDR) 2017/745, while not explicitly naming a "Quality Manual," requires manufacturers to establish, implement, maintain, and continually improve a quality management system as described in Annex IX, which implicitly necessitates such a foundational document. ISO 13485:2016, specifically clause 4.2.2, provides detailed requirements for the content of a Quality Manual, including the scope of the Quality Management System (QMS), documented procedures, and descriptions of processes and their interactions.

What this means in practice

Often the first document an auditor opens; clarity and accuracy here set the tone for the rest of the audit.

Examples

A MedTech startup developing a new diagnostic device drafts a Quality Manual that details its quality policy, the scope of its QMS, and references to its design control procedures, as required by 21 CFR 820.30.
During an ISO 13485 certification audit, an auditor reviews a medical device manufacturer's Quality Manual to confirm that it clearly outlines the interactions between their production and post-market surveillance processes, as specified in ISO 13485:2016 clause 4.2.2.
A company expanding its product line updates its Quality Manual to include the new product categories within its QMS scope and adds references to new risk management procedures, aligning with EU MDR Annex I General Safety and Performance Requirements.

Common pitfalls

•A common pitfall is treating the Quality Manual as a static document, failing to update it to reflect changes in the QMS or regulatory landscape.
•Another mistake is writing a Quality Manual that is too generic, lacking specific details about the manufacturer's unique processes and products.
•Manufacturers sometimes overlook the importance of linking the Quality Manual to other QMS documents, leading to an incoherent system.
•Failing to justify any exclusions from ISO 13485 requirements within the Quality Manual can lead to non-conformities during audits.
•An improperly organized Quality Manual can make it difficult for auditors to navigate, potentially delaying or complicating the audit process.

Frequently asked questions

The primary purpose is to provide a high-level overview of an organization's Quality Management System, demonstrating how it meets applicable regulatory and standard requirements. It serves as a foundational document for the entire QMS.

Grouped by theme

Editor's picks

· Hand-selected related concepts

Quality & Risk

Quality System Regulation(QSR / 21 CFR 820)

FDA's current good manufacturing practice (cGMP) requirements for medical devices.

Standards

ISO 13485

International standard for medical device quality management systems.

Latest in MedTech

Sources

3 sources

Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1

Link health: 3 verified· last checked 2026-06-20

ISO·2FDA·1

Inline markers like [1] jump to the matching reference above.

My progress

All terms0 / 513

Quality & Risk0 / 39

Saved on this device, and to your account when signed in. View studied terms

Full glossary

Browse all terms A to Z, each with a short definition.

On this term

Category: Quality & Risk
Sources: 3
Updated: 9/19/2026

Compare with another term

Learn in 60 seconds

Top-level QMS document describing scope, processes, and their interactions.

·Often the first document an auditor opens; clarity and accuracy here set the tone for the rest of the audit.
·The quality manual also outlines the structure of the documentation used in the QMS and is often the first document reviewed by auditors.
·ISO 13485 allows exclusions or non-applications, for example of design and development, only when justified and allowed by applicable regulations.

Remember this

Watch out: A common pitfall is treating the Quality Manual as a static document, failing to update it to reflect changes in the QMS or regulatory landscape.

Related terms

You may also need

Auto-suggested from Quality & Risk and shared keywords.

All Quality & Risk terms

From the Blue Goat network

Related resources and services on this topic.

MedTech Truths
Common misconceptions about medical device development - debunked.